Clinical trial

Comparative Study Between Intra Articular Injection of Ozone With Corticosteroids Versus Plasma Rich in Growth Factors in Limitation of Pain in Knee Osteoarthritis

Name

35293/2/22

Description

The aim of this study is to compare the effectiveness of intra-articular injection of ozone with corticosteroids versus plasma rich in growth factors (PRGF) in improvement of pain in knee osteoarthritis patients.

Trial arms

Trial start

2022-06-01

Estimated PCD

2023-05-20

Trial end

2023-05-20

Status

Completed

Treatment

Intra-articular Ozone and corticosteroids

patients will undergo one session a week for a total of four sessions of intra-articular knee injection with combination of 5ml (25 μg/ml) ozone injection + 2 ml lignocaine 2% + 2 ml Betamethasone sodium phosphate 4 mg. Under aseptic precautions. A22-gauge needle was positioned inferior-laterally into the infera-patellar pouch, injection of 2 ml of 4 mg Betamethasone sodium phosphate, and 2 ml injection lignocaine 2% was injected slowly (over 1-2 minutes). The needle was left in space for the 5 ml (25 μg/ml) ozone injection. Patients were advised to avoid strenuous activity for 2-3 days following the intra-articular injection.

Arms:

Group ozone

intra-articular PRGF Method

Patients will undergoes two doses with 2 weeks interval by injection of already synthetic plasma rich in growth factors \[PRGF\] vial intra-articularly. This vial is formed of lyophilized cake of platelet growth factors in a tightly sealed container stored at 2-8◦C which synthesized under complete aseptic technique by activation of platelets to release its growth factors and cytokines which help in knee cartilage regeneration and act as potent anti-inflammatory to reduce the pain. Prior to usage, reconstitution of the product was done using 1 ml saline and 1 ml lignocaine 2% followed by gentle vial rubbing for 3 min then, the mixture was kept at ambient temperature for 5 min to ensure complete protein re-hydration.

Arms:

Group PRGF(plasma rich in growth factors)

Size

Primary endpoint

knee osteoarthritis pain

six months following injection

Decrease of Analgesic requirement for pain control after injection

six months following injection

Eligibility criteria

Inclusion Criteria: * Patients aged 21-65 years * both genders * who will be diagnosed with stage 2-3 knee osteoarthritis according to the Kellgren-Lawrence Classification System (K-L) \[10\], with WOMAC Score \> 2 for pain stiffness and physical disabilities * having symptoms of Knee OA at least 3 months after getting usual conservative treatment like oral analgesics and Therapeutic Exercises. Exclusion Criteria: * Patient refusal. * Patients who will be diagnosed with Stage 1or 4 OA according to K-L Classification * History of knee trauma within the past month * History of malignancies * Any surgical intervention of the knee * Local or systemic infection * Any patient with sever renal Impairment * Bleeding disorders

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

Updated at

2024-02-20

1 organization

2 products

4 indications

Organization

Tanta University

Product

Intra-articular Ozone and corticosteroids

Indication

Intra-Articular Injection

Indication

Corticosteroids

Indication

Plasma Rich in Growth Factors

Indication

Osteoarthritis, Knee

Product

intra-articular PRGF Method